Acute Myelogenous Leukemia Clinical Trial
Official title:
A Phase I Study of Lenalidomide Plus Chemotherapy With Mitoxantrone, Etoposide, and Cytarabine for the Reinduction of Patients With Acute Myelogenous Leukemia
Verified date | March 2016 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of
an investigational combination of drugs. Phase I studies also try to define the appropriate
dose of the investigational combination of drugs to use for further studies.
"Investigational" means that the combination of drugs is still being studied and that
research doctors are trying to find out more about it. It also means that the FDA has not
approved this combination of drugs for AML. As part of this research study, you will take
lenalidomide in combination with MEC. MEC are FDA approved chemotherapy drugs that are
commonly used in the treatment of AML. Lenalidomide is approved by the FDA for patients with
multiple myeloma, and some patients with myelodysplasia. Lenalidomide is considered
investigational in this research study because it is not approved by the FDA for patients
with AML.
Lenalidomide is a drug that affects the immune system, called an immunomodulatory drug or
IMID. This drug is successful in the treatment of patients with multiple myeloma and some
patients with myelodysplasia, a pre-leukemic condition. Other research studies suggest that
lenalidomide may also be effective in patients with AML. Since we know that many patients
who receive MEC chemotherapy alone do not have a prolonged remission (time free from
leukemia), we are studying the addition of lenalidomide to MEC.
In this research study, we are looking for the highest dose of lenalidomide that can be
given safely with MEC.
Status | Completed |
Enrollment | 36 |
Est. completion date | December 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Primary refractory disease following at least one cycle of induction therapy or first relapse or higher - Must be registered into RevAssist program - Able and willing to adhere to study schedule and other protocol requirements Exclusion Criteria: - Pregnant or breastfeeding - Known hypersensitivity to thalidomide or lenalidomide - Known seropositive for HIV - Have had myocardial infarction within 6 months of enrollment or NYHA Class III or IV heart failure - Other serious medical conditions or psychiatric conditions - Major surgery within 28 days prior to treatment - Received investigational agent or cytotoxic chemotherapy (except hydroxyurea) within 2 weeks of study - Acute promyelocytic leukemia |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of lenalidomide plus conventional chemotherapy for relapsed AML | Evaluation of the safety of lenalidomide in combination with conventional chemotherapy for relapsed acute myelogenous leukemia. Dose limiting toxicity is defined as a Grade IV rash or delayed neutrophil or platelet recovery beyond Day 45 after start of chemotherapy in the absence of disease | 2 years | Yes |
Secondary | Days to neutrophil recovery | Evaluation of neutrophil recovery (the first 3 days of ANC>500) | 2 years | No |
Secondary | Complete Remission Rate | Evaluation of the complete remission rate and the complete remission rate without platelet recovery | 2 years | No |
Secondary | Treatment-related mortality | Evaluation of the treatment-related mortality, the number of non-relapse related deaths in the first 45 days of starting treatment | 2 years | Yes |
Secondary | Transfusion Support | Evaluation of transfusion support, the number of red blood cell and platelet transfusions needed in the first 45 days of treatment | 2 years | No |
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